Minimally Invasive Repair of a Valve Leaflet in a Beating Heart

ABSTRACT

A device for performing minimally invasive repair of mitral valve leaflets in a beating heart through the delivery and implantation of artificial chordae tendineae includes a handle for positioning the device into a chest cavity of the patient, a capture assembly adapted to capture a valve leaflet between distal an proximal tip portions, a needle adapted to penetrate the valve leaflet, and a capture confirmation system for verifying capture of the valve leaflet between the distal and proximal tip potions.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/678,571 filed Nov. 8, 2019, now U.S. Pat. No. 11,419,602, which is acontinuation of U.S. application Ser. No. 14/310,807 filed Jun. 20,2014, now U.S. Pat. No. 10,507,018, which is a continuation of U.S.application Ser. No. 12/254,807 filed Oct. 20, 2008, now U.S. Pat. No.8,758,393, which claims the benefit of U.S. Provisional Application No.60/999,431, filed Oct. 18, 2007, U.S. Provisional Application No.60/999,635, filed Oct. 19, 2007, and U.S. Provisional Application No.60/999,873, filed Oct. 22, 2007, which are incorporated herein in theirentirety by reference.

FIELD OF THE INVENTION

The present invention relates to minimally invasive delivery of asuture. More particularly, the present invention relates to attachingartificial chordae tendineae to a flailing or prolapsing leaflet in abeating heart.

BACKGROUND OF THE INVENTION

Various types of surgical procedures are currently performed toinvestigate, diagnose, and treat diseases of the heart and the greatvessels of the thorax. Such procedures include repair and replacement ofmitral, aortic, and other heart valves, repair of atrial and ventricularseptal defects, pulmonary thrombectomy, treatment of aneurysms,electrophysiological mapping and ablation of the myocardium, and otherprocedures in which interventional devices are introduced into theinterior of the heart or a great vessel.

Using current techniques, many of these procedures require a grossthoracotomy, usually in the form of a median sternotomy, to gain accessinto the patient's thoracic cavity. A saw or other cutting instrument isused to cut the sternum longitudinally, allowing two opposing halves ofthe anterior or ventral portion of the rib cage to be spread apart. Alarge opening into the thoracic cavity is thus created, through whichthe surgical team may directly visualize and operate upon the heart andother thoracic contents.

Surgical intervention within the heart generally requires isolation ofthe heart and coronary blood vessels from the remainder of the arterialsystem, and arrest of cardiac function. Usually, the heart is isolatedfrom the arterial system by introducing an external aortic cross-clampthrough a sternotomy and applying it to the aorta between thebrachiocephalic artery and the coronary ostia. Cardioplegic fluid isthen injected into the coronary arteries, either directly into thecoronary ostia or through a puncture in the aortic root, so as to arrestcardiac function. In some cases, cardioplegic fluid is injected into thecoronary sinus for retrograde perfusion of the myocardium. The patientis placed on cardiopulmonary bypass to maintain peripheral circulationof oxygenated blood.

Of particular interest to the present invention are intracardiacprocedures for surgical treatment of heart valves, especially the mitraland aortic valves. According to recent estimates, more than 79,000patients are diagnosed with aortic and mitral valve disease in U.S.hospitals each year. More than 49,000 mitral valve or aortic valvereplacement procedures are performed annually in the U.S., along with asignificant number of heart valve repair procedures.

Various surgical techniques may be used to repair a diseased or damagedvalve, including annuloplasty (contracting the valve annulus),quadrangular resection (narrowing the valve leaflets), commissurotomy(cutting the valve commissures to separate the valve leaflets),shortening mitral or tricuspid valve chordae tendonae, reattachment ofsevered mitral or tricuspid valve chordae tendonae or papillary muscletissue, and decalcification of valve and annulus tissue. Alternatively,the valve may be replaced by excising the valve leaflets of the naturalvalve and securing a replacement valve in the valve position, usually bysuturing the replacement valve to the natural valve annulus. Varioustypes of replacement valves are in current use, including mechanical andbiological prostheses, homografts, and allografts.

The mitral valve, located between the left atrium and left ventricle ofthe heart, is most easily reached through the wall of the left atrium,which normally resides on the posterior side of the heart, opposite theside of the heart that is exposed by a median sternotomy. Therefore, toaccess the mitral valve via a sternotomy, the heart is rotated to bringthe left atrium into a position accessible through the sternotomy. Anopening, or atriotomy, is then made in the left atrium, anterior to theright pulmonary veins. The atriotomy is retracted by means of sutures ora retraction device, exposing the mitral valve directly posterior to theatriotomy. One of the aforementioned techniques may then be used torepair or replace the valve.

An alternative technique for mitral valve access may be used when amedian sternotomy and/or rotational manipulation of the heart are/isundesirable. In this technique, a large incision is made in the rightlateral side of the chest, usually in the region of the fifthintercostal space. One or more ribs may be removed from the patient, andother ribs near the incision are retracted outward to create a largeopening onto the thoracic cavity. The left atrium is then exposed on theposterior side of the heat, and an atriotomy is formed in the wall ofthe left atrium, through which the mitral valve may be accessed forrepair or replacement.

The mitral and tricuspid valves inside the human heart include anorifice (annulus), two (for the mitral) or three (for the tricuspid)leaflets and a subvalvular apparatus. The subvalvular apparatus includesmultiple chordae tendineae, which connect the mobile valve leaflets tomuscular structures (papillary muscles) inside the ventricles. Ruptureor elongation of the chordae tendineae result in partial or generalizedleaflet prolapse, which causes mitral (or tricuspid) valveregurgitation. A commonly used technique to surgically correct mitralvalve regurgitation is the implantation of artificial chordae (usually4-0 or 5-0 Gore-Tex sutures) between the prolapsing segment of the valveand the papillary muscle. This operation is generally carried outthrough a median sternotomy and requires cardiopulmonary bypass withaortic cross-clamp and cardioplegic arrest of the heart.

Using such open-chest techniques, the large opening provided by a mediansternotomy or right thoracotomy enables the surgeon to see the mitralvalve directly through the left atriotomy, and to position his or herhands within the thoracic cavity in close proximity to the exterior ofthe heart for manipulation of surgical instruments, removal of excisedtissue, and/or introduction of a replacement valve through the atriotomyfor attachment within the heart. However, these invasive open-chestprocedures produce a high degree of trauma, a significant risk ofcomplications, an extended hospital stay, and a painful recovery periodfor the patient. Moreover, while heart valve surgery produces beneficialresults for many patients, numerous others who might benefit from suchsurgery are unable or unwilling to undergo the trauma and risks ofcurrent techniques.

One alternative to open heart surgery is a robotically guided,thoracoscopically assisted cardiotomy procedure marketed under thetradename of the DaVinci® system. Instead of requiring a sternotomy, theDaVinci® system uses a minimally invasive approach guided by cameravisualization and robotic techniques. Unfortunately, the DaVinci® systemis not approved for mitral valve repair procedures on a beating heart.Thus, the use of the DaVinci® system for mitral valve repair stillrequires a cardiopulmonary bypass with aortic cross-clamp andcardioplegic arrest of the heart.

While there are other laparoscopic and minimally invasive surgicaltechniques and tools that have been developed, none of these devices areuseable for the unique requirements of mitral valve repair on a beatingheart. Suturing devices like the Superstich™ vascular suturing device orthe Gore® suture passer are designed to permit manual placement ofsutures as part of a surgical procedure, but are not designed for use ona beating heart. While certain annuloplasty techniques and instrumentsthat can suture an annuloplasty ring as part of vascular repair or heartbypass surgery may be used in conjunction with a beating heart, theseannuloplasty procedures do not involve the capture or retention of aconstantly moving leaflet. Consequently, the design and use ofannuloplasty techniques and instruments are of little help in solvingthe problems of developing instruments and techniques for minimallyinvasive thoracoscopic repair of heart valves.

Recently, a technique has been developed for minimally invasivethoracoscopic repair of heart valves while the heart is still beating.Int'l Pub. No. WO 2006/078694 A2 to Speziali discloses a thoracoscopicheart valve repair method and apparatus. Instead of requiring open heartsurgery on a stopped heart, the thorascopic heart valve repair methodsand apparatus taught by Speziali utilize fiber optic technology inconjunction with transesophageal echocardiography (TEE) as avisualization technique during a minimally invasive surgical procedurethat can be utilized on a beating heart. U.S. Publication No.2008/0228223 to Alkhatib also discloses a similar apparatus forattaching a prosthetic tether between a leaflet of a patient's heartvalve and another portion of the patient's heart to help preventprolapse of the leaflet and/or to otherwise improve leaflet function.

While the Speziali invention represents a significant advance over openheart techniques for heart valve repair, it would be advantageous tofurther improve upon this new technique.

SUMMARY OF THE INVENTION

Embodiments of the present invention are generally directed to apparatusand methods for minimally invasive surgical procedures. Althoughembodiments of the present invention disclosed herein may be adapted orused for any number of purposes, the present invention can generally beused to repair mitral valve leaflets by delivering an implanting one ormore sutures to function as artificial chordae tenindae.

In an embodiment, a device for repairing a valve leaflet in a beatingheart of a patient comprises a handle assembly, a capture assembly, anda needle head. The handle assembly includes a shaft extending from adistal end of the handle adapted to be extended into a chest cavity ofthe patient and an actuator mechanism positioned proximate a proximalend of the handle assembly. The shaft has a diameter and a generallycircular cross-section along a longitudinal axis at a distal portion ofthe shaft that is adapted to pass through an incision in the beatingheart. The capture assembly extends from the distal portion of the shaftand is adapted to be positioned within the beating heart. The captureassembly has a distal portion including a clamping mechanism adapted tograsp and release the valve leaflet and a proximal portion operablyconnected to the shaft. The distal portion of the capture assembly has amaximum diameter of an asymmetric cross section transverse to thelongitudinal axis of the capture assembly that is greater than thediameter of the shaft. One of a first clamping jaw or a second clampingjaw of the clamping mechanism is selectively positionable along alongitudinal axis of the capture assembly in response to actuation ofthe actuator mechanism to create a space between interior surfaces ofthe first clamping jaw and the second clamping jaw having an asymmetricperimeter. The needle head is slidably positionable within the captureassembly to engage a suture at least partially carried by the captureassembly in response to selective activation of a needle by the actuatormechanism as the needle penetrates the valve leaflet. The area of theinterior surfaces is increased relative to an interior surface area of acircular clamping jaw having a diameter equal to the diameter of theshaft. The capture assembly is rotatable within the heart with reducedblood loss relative to blood loss of rotation of the asymmetricperimeter of the first clamping jaw and the second clamping jaw in theincision of the heart.

In further embodiments the first clamping jaw and the second clampingjaw may be separable along a bifurcation plane. The bifurcation planemay form a bifurcation angle with the longitudinal axis of the captureassembly. The bifurcation angle may be between approximately forty-fivedegrees and ninety degrees, or between approximately fifty-five degreesand approximately sixty-five degrees. The area of the interior surfacesmay be increased relative to the interior surface area of a circularclamping jaw having a diameter equal to the diameter of the shaft bybetween 20% and 100%, or between 30% and 50%. The diameter of the shaftmay be less than 12 mm, or less than 9 mm. The space between interiorsurfaces of the first clamping jaw and the second clamping jaw of thedistal tip portion, when positioned in an open position, may provides adistance along the longitudinal axis of the capture assembly betweeninterior surfaces of the first clamping jaw and the second clamping jawof between 1 and 5 cm, or between 2 and 3 cm. The capture assembly maybe configured to penetrate the valve leaflet with the needle head from adistance of between approximately one millimeter and approximately fourmillimeters from a leading edge of the valve leaflet. The distal portionof the shaft may be isodiametric and the proximal portion of the captureassembly may include a tapered region having cross sections thattransition from a substantially circular cross section of the distalportion of the shaft to the asymmetric perimeter of the first clampingjaw and the second clamping jaw. The distal portion of the captureassembly may have a generally oblong asymmetric egg three dimensionalshape, with the bifurcation angle being approximately 60 degrees and theasymmetric perimeter of the first clamping jaw and the second clampingjaw being generally loaf shaped cross section.

In an embodiment, a device for repairing a valve leaflet in a beatingheart of a patient comprises a shaft, a handle, a capture assembly, anda needle. The shaft has a proximal end outside the patient and a distalend adapted for insertion into the beating heart of the patient. Thehandle has an actuator operably connected to the proximal end of theshaft. The capture assembly is adapted to penetrate the beating heart,operably coupled to the distal end of the shaft, and includes a clampingmechanism, bifurcated tip, adapted to grasp the valve leaflet inresponse to selective actuation of the actuator. The needle is slidablypositionable within the capture assembly to penetrate the valve leaflet.The shaft is generally isodiametric. The capture assembly has across-sectional perimeter that is asymmetric at the bifurcated tip. Amaximum diameter of the cross sectional perimeter at the bifurcated tipis greater than a diameter of a portion of the shaft adapted to bepositioned proximate a wall of the beating heart.

In further embodiments, the handle may include a first actuatorextending generally outwardly the handle for lateral operation and asecond actuator generally axially along the handle for inline operation.The first actuator may be operably connected to the needle assembly andthe second actuator may be operably connected to the capture assembly.The handle may define a first and second spaced-apart aperture and theactuator may define a third aperture. The first, second, and thirdapertures may be adapted to receive fingers of an operator. The handleand the actuator may also be adapted for robotic control. The roboticcontrol may be performed by a multi-axis control system. The captureassembly may include a pivot joint operably controllable by themulti-axis control system. The capture assembly may be pivotable aboutat least two axes of rotation.

In an embodiment, device for repairing a valve leaflet in a beatingheart of a patient comprises a handle assembly, a capture assembly, aneedle head, and a capture confirmation system. The handle assemblyincludes a shaft extending from a distal end of the handle adapted to beextended into a chest cavity of the patient and an actuator mechanismpositioned proximate a proximal end of the handle assembly. The captureassembly extends from the distal portion of the shaft and is adapted tobe positioned within the beating heart. The capture assembly has adistal portion including a clamping mechanism adapted to grasp andrelease the valve leaflet. The capture assembly also has a proximalportion operably connected to the shaft. A first clamping jaw of theclamping mechanism is selectively positionable along a longitudinal axisof the capture assembly in response to actuation of the actuatormechanism to create a space between interior surfaces of the firstclamping jaw and a second clamping jaw. The clamping mechanism has anasymmetric perimeter. The capture assembly further includes a pluralityof pairs of fiber optic fibers. Each pair of fibers has a transmissionfiber and a return fiber terminated on a distal end at an interiorsurface of the clamping mechanism where the fiber extends through theshaft and out of the handle assembly to a proximal end beyond the handleassembly. The needle head is slidably positionable within the captureassembly to engage a suture at least partially carried by the captureassembly in response to selective activation of a needle by the actuatormechanism as the needle penetrates the valve leaflet. The captureconfirmation system verifies capture of the valve leaflet in the spacebetween the interior surfaces of the first clamping jaw and the secondclamping jaw. The capture confirmation system includes a housingseparate from the handle assembly and at least one lense. The housingseparate from the handle assembly contains a battery powered opticallight source in optical communication with a proximal end of eachtransmission fiber. The at least one lens is visible from an exteriorsurface of the housing and in optical communication with a proximal endof each return fiber to display light received from the space betweenthe interior surfaces of the first clamping jaw and the second clampingjaw corresponding to the distal end of each return fiber as anindication of whether there is capture of the valve leaflet by thecapture assembly.

In further embodiments, the capture confirmation system may provide abinary indication of whether the valve leaflet is grasped between theinterior surfaces of the first clamping jaw and the second clamping jawby displaying a first color when a surface of the valve leafletconfronts the fiber optic pairs at the interior surfaces and a secondcolor when the valve leaflet does not confront the fiber optic pairs atthe interior surfaces. The first color may be indicative of blood andthe second color is indicative of valve leaflet. The optical lightsource may be a light-emitting diode (LED) and the proximal end of thetransmission fiber may be positioned less than approximately 0.5 cm fromthe LED, or between approximately 0.1 cm and approximately 0.2 cm fromthe LED. Each lens may have a thickness of between approximately 0.2 cmand approximately 0.5 cm, or between approximately 0.3 cm andapproximately 0.35 cm. The proximal end of each return fiber may bepositioned within approximately 0.3 cm of the corresponding lens, orbetween approximately 0.15 cm and approximately 0.2 cm of thecorresponding lens. The shaft may define a needle lumen adapted toreceive the needle and the pairs of fiber optic fibers may be carried bythe shaft outside the needle lumen. Each pair of fiber optic fibers mayinclude at least approximately 1 m of length external to the handle suchthat the housing of the capture confirmation system is positionableproximal a separate patient display apparatus after insertion of thedevice into the chest cavity of the patient.

In an embodiment, a device for repairing a valve leaflet in a beatingheart of a patient comprises a handles assembly, a capture assembly, anda needle head. The handle assembly includes a shaft extending from adistal end of the handle and is adapted to be extended into a chestcavity of the patient. The shaft includes a first channel adapted toreceive a suture and a second channel adapted to receive a needle. Thehandle assembly also includes an actuator mechanism and a sutureretention mechanism. The capture assembly extends from a distal portionof the shaft and is adapted to be positioned within the beating heart.The capture assembly has a distal portion including a clamping mechanismadapted to grasp and release the valve leaflet and a proximal portionoperably connected to the shaft. The needle head is slidablypositionable within the capture assembly to engage the suture at leastpartially carried by the capture assembly in response to selectiveactivation of the needle by the actuator mechanism as the needlepenetrates the valve leaflet. The suture retention mechanism selectivelytensions the suture across a path of travel of the needle through theneedle head prior to engagement by the needle.

In further embodiments, the capture assembly may define a needle detentand the suture may be substantially taught across the needle detent. Theneedle head may present a hook adapted to receive the suture.

In an embodiment, a device for repairing a valve leaflet in a beatingheart of a patient may comprise a handle assembly, a capture assembly,and a needle head. The handle assembly includes a shaft and an actuatormechanism. The shaft extends from a distal end of the handle and isadapted to be extended into a chest cavity of the patient. The actuatormechanism is positioned proximate a proximal end of the handle assembly.The capture assembly extends from the distal portion of the shaft and isadapted to be positioned within the beating heart. The capture assemblyhas a distal portion and a proximal portion. The distal portion includesa clamping mechanism adapted to grasp and release the valve leaflet. Theproximal portion is operably connected to the shaft. A first clampingjaw of the clamping mechanism is selectively positionable along alongitudinal axis of the capture assembly in response to actuation ofthe actuator mechanism to create a space between interior surfaces ofthe first clamping jaw and a second clamping jaw. The needle head isslidably positionable within the capture assembly to engage a suture atleast partially carried by the capture assembly in response to selectiveactivation of a needle by the actuator mechanism as the needlepenetrates the valve leaflet. At least one of the handle assembly or thecapture assembly includes a biasing member adapted to bias at least oneof the first clamping jaw and the second clamping jaw with respect toone another such that selective actuation of the actuator mechanismovercomes the biasing member before the space is created or closedbetween the interior surfaces of the first clamping jaw and the secondclamping jaw.

In further embodiments, the first clamping jaw and the second clampingjaw may be biased toward a closed position. The biasing member may exerta force of between approximately one pound per square-inch andapproximately ten pounds per square-inch, or approximately five poundsper square-inch.

In an embodiment, a method of repairing a valve leaflet in a beatingheart of a patient includes using any of the embodiments of the devicesdescribed heretofore.

In an embodiment, a method of providing instruments and instructions forrepairing a valve leaflet comprises any of the embodiments of thedescribed heretofore and providing instructions for operating any of theembodiments described heretofore to repair the valve leaflet.

In further embodiments, the device can be used in conjunction withexternal transesophageal echocardiography (TEE) to visualize a valveleaflet to verify leaflet capture. In various embodiments, the devicecan provide assistance in performing repair of heart valves through amidline sternotomy during cardiopulmonary by-pass thoracotomymodalities, including anterolateral thoracotomy, in addition tominimally invasive procedures.

Throughout the specification, any references to such relative terms astop and bottom, and the like are intended for convenience of descriptionand are not intended to limit the present invention or its components toany one positional or spatial orientation. It will be further understoodthat various dimensions of the components in the attached figures mayvary depending upon specific applications and intended use of theinvention without departing from the scope of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments of the present invention may be more completelyunderstood in consideration of the following detailed description ofvarious embodiments in connection with the accompanying drawings, inwhich:

FIG. 1A is a perspective view of a device for delivering andmanipulating a suture in a beating heart, according to an embodiment ofthe present invention;

FIG. 1B is a perspective view of a device for delivering andmanipulating a suture in a beating heart, according to an embodiment ofthe present invention;

FIG. 2 is a front/top perspective view of the handheld suture deploymentdevice depicted in FIG. 1A;

FIG. 3 is a front/top perspective view of the handheld suture deploymentdevice depicted in FIG. 1A;

FIG. 4A is a front/top perspective view of the distal tip of thehandheld suture deployment device depicted in FIG. 1A;

FIG. 4B is a front/top perspective view of the distal tip of thehandheld suture deployment device depicted in FIG. 2 ;

FIG. 4C is a side elevation view of the distal tip of the handheldsuture deployment device depicted in FIG. 2 ;

FIG. 4D is a rear/side perspective view of the open distal tip of thehandheld suture deployment device depicted in FIG. 2 ;

FIG. 4E is a front/side perspective view of the open distal tip of thehandheld suture deployment device depicted in FIG. 2 ;

FIG. 4F is a front/bottom perspective view of the upper clamp jaw andshaft of the handheld suture deployment device depicted in FIG. 2 ;

FIG. 4G is a front/side perspective view of the open distal tip of thehandheld suture deployment device depicted in FIG. 2 ;

FIG. 4H is a side elevation view of the open distal tip of the handheldsuture deployment device depicted in FIG. 2 ;

FIG. 4I is a rear/top perspective view of the open distal tip of thehandheld suture deployment device depicted in FIG. 2 ;

FIG. 4J is a rear/top perspective view of the open distal tip of thehandheld suture deployment device depicted in FIG. 2 ;

FIG. 5 is a front/top perspective view of the pre-loaded suturecartridge depicted in FIG. 2 ;

FIG. 5A (view A cartridge in phantom) is a front/top perspective view ofthe distal end of a pre-loaded suture cartridge;

FIG. 5B (view B) is a front/top perspective view of the proximal end ofa pre-loaded suture cartridge;

FIG. 5C (view A, rotated, cartridge in phantom) is a rear/topperspective view of the distal end of a pre-loaded suture cartridge;

FIG. 5D (view A, rotated) is a rear/top perspective view of the distalend of a pre-loaded suture cartridge;

FIG. 5E (view B, cartridge in phantom) is a front/top perspective viewof the proximal end of a pre-loaded suture cartridge;

FIG. 6 is a front/top perspective view of the operating room loadedcartridge depicted in FIG. 3 ;

FIG. 6A (rotated) is a rear/top perspective view of the distal end of aoperating room loaded cartridge;

FIG. 7 is a front/top perspective view of the needle assembly depictedin FIG. 1A;

FIG. 7A is a front/top perspective view of the distal end of a needleassembly;

FIG. 8 is a rear/top perspective view of an extended needle within theopen distal tip of the handheld suture deployment device depicted inFIG. 1A;

FIG. 8A is a front/top perspective view of the proximal end of thehandheld suture deployment device depicted in FIG. 1A with the needleassembly in the start position;

FIG. 8B is a front/top perspective view of the proximal end of thehandheld suture deployment device depicted in FIG. 1A with the needleassembly in the start position;

FIG. 8C is a front/top perspective view of the proximal end of thehandheld suture deployment device depicted in FIG. 1A with the needleassembly in the fully advanced position;

FIG. 8D is a front/top perspective view of the proximal end of thehandheld suture deployment device depicted in FIG. 1A with a retractedneedle assembly;

FIG. 9 is a front/top perspective view of the proximal end of thehandheld suture deployment device depicted in FIG. 1A (with certainparts omitted for clarity);

FIG. 10 is a rear/bottom perspective view of the proximal end of thehandheld suture deployment device depicted in FIG. 1A;

FIG. 11 is a front/top perspective view of the plunger assembly depictedin FIG. 8A;

FIG. 12 is a front/top perspective view depicting fiber optic cableassembly depicted in FIG. 1A and leaflet capture verification monitordepicted in FIG. 1A;

FIG. 13 is an exploded front/top perspective view of the fiber opticcable assembly depicted in FIG. 12 ;

FIG. 14 is a front/bottom perspective view of a mitral valve leaflet inneed of repair, and the distal end of the handheld suture deploymentdevice depicted in FIG. 1A;

FIG. 15 is a front/bottom perspective view of a mitral valve leaflet inneed of repair, and the distal end of the handheld suture deploymentdevice depicted in FIG. 1A;

FIG. 16 is a front/bottom perspective view of a mitral valve leaflet inneed of repair captured by the clamp of the handheld suture deploymentdevice depicted in FIG. 1A;

FIG. 17 is a front perspective view of the leaflet capture verificationmonitor depicted in FIG. 1A;

FIG. 18 is a front perspective view of the leaflet capture verificationmonitor depicted in FIG. 1A;

FIG. 19 is a side/bottom perspective view of a mitral valve leafletcaptured by the clamp of the handheld suture deployment device depictedin FIG. 1A;

FIG. 20 is a side/bottom perspective view of a mitral valve leafletcaptured by the clamp of the handheld suture deployment device depictedin FIG. 1A;

FIG. 21 is a side/bottom perspective view of a mitral valve leafletcaptured by the clamp of the handheld suture deployment device depictedin FIG. 1A, with the clamp shown in phantom;

FIG. 22 is a side/bottom perspective view of a mitral valve leafletcaptured by the clamp of the handheld suture deployment device depictedin FIG. 1A, with the clamp shown in phantom;

FIG. 23 is a side/bottom perspective view of a mitral valve leaflet inneed of repair captured by the clamp of the handheld suture deploymentdevice depicted in FIG. 1A, with the clamp shown in phantom;

FIG. 24 is a side/bottom perspective view of a mitral valve leaflet inneed of repair captured by the clamp of the handheld suture deploymentdevice depicted in FIG. 1A, with the clamp shown in phantom;

FIG. 25 is a side/bottom perspective view of a mitral valve leaflet inneed of repair captured by the clamp of the handheld suture deploymentdevice depicted in FIG. 1A, with the clamp shown in phantom;

FIG. 26 is a side/bottom perspective view of a mitral valve leaflet inneed of repair captured by the clamp of the handheld suture deploymentdevice depicted in FIG. 1A, with the clamp shown in phantom;

FIG. 27 is a side/bottom perspective view of a mitral valve leaflet inneed of repair captured by the clamp of the handheld suture deploymentdevice depicted in FIG. 1A, with the clamp shown in phantom;

FIG. 28 is a top/rear perspective view of the handheld suture deploymentdevice depicted in FIG. 1A;

FIG. 29 is a top/rear perspective view of the handheld suture deploymentdevice depicted in FIG. 1A;

FIG. 30 is a top/rear perspective view of the handheld suture deploymentdevice depicted in FIG. 1A and the needle assembly depicted in FIG. 1Apartially retracted from the handheld suture deployment device;

FIG. 31 is a top/rear perspective view of the handheld suture deploymentdevice depicted in FIG. 1A, the needle assembly depicted in FIG. 1Aretracted from the handheld suture deployment device, and the suturedepicted in FIG. 1A;

FIG. 32 is a top/rear perspective view of the handheld suture deploymentdevice depicted in FIG. 1A, the needle assembly depicted in FIG. 1Aretracted from the handheld suture deployment device, and the suturedepicted in FIG. 1A;

FIG. 33 is a front/bottom perspective view of a mitral valve leaflet inneed of repair, and the distal end of the handheld suture deploymentdevice depicted in FIG. 1A partially retracted from the heart chamber;

FIG. 34 is a front/bottom perspective view of a mitral valve leaflet inneed of repair, and the distal end of the handheld suture deploymentdevice depicted in FIG. 1A partially retracted from the heart chamber;

FIG. 35 is a front/bottom perspective view of a mitral valve leaflet inneed of repair, and the distal end of the handheld suture deploymentdevice depicted in FIG. 1A partially retracted from the heart chamber;

FIG. 36 is an perspective view of the loop and non-loop ends of thesuture depicted in FIG. 1A;

FIG. 37 is an perspective view of the loop and non-loop ends of thesuture depicted in FIG. 1A;

FIG. 38 is an perspective view of the loop and non-loop ends of thesuture depicted in FIG. 1A;

FIG. 39 is a front/bottom perspective view of a mitral valve leaflet inneed of repair, and a loose girth hitch on the leaflet;

FIG. 40 is a front/bottom perspective view of a mitral valve leaflet inneed of repair, and a loose girth hitch on the leaflet;

FIG. 41 is a front/bottom perspective view of a mitral valve leaflet inneed of repair, and an adjusted girth hitch on the leaflet;

FIG. 42 is screen capture of the display of an external transesophagealechocardiography showing a reduction in MR;

FIG. 43 is a schematic top plan view of a mitral valve;

FIG. 44 is a cross-sectional view of a heart;

FIG. 45A is a cross-sectional view of a heart with a normal mitralvalve;

FIG. 45B is a partial cross-sectional view of a heart with an abnormalmitral valve;

FIG. 46 is an perspective partial cut-away front view of apical accessof a heart with insets showing the mitral valve leaflets and chordaetendonae;

FIG. 47 is a view of a surgeon tensioning a suture and of a suturesecuring a leaflet;

FIG. 48 is a view of a suture securing a leaflet;

FIG. 49 is a series of side elevation views of the open distal tip ofthe handheld suture deployment device depicted in FIG. 2 capturing aleaflet, and two front perspective views of the leaflet captureverification monitor depicted in FIG. 1A;

FIG. 50 is a top/rear perspective view of the open distal tip of thehandheld suture deployment device depicted in FIG. 2 ;

FIG. 51 is a top/front perspective view of the open distal tip of thehandheld suture deployment device depicted in FIG. 2 ;

FIG. 52 is a top plan view of the open distal tip of the handheld suturedeployment device depicted in FIG. 2 ;

FIG. 53 is a front perspective view of the open distal tip of thehandheld suture deployment device depicted in FIG. 2 .

FIG. 54A-C is a top plan view and a side elevation view of the suturecartridge depicted in FIG. 1A; and

FIG. 55 is a side elevation view and a front/bottom perspective view ofthe shaft depicted in FIG.1A.

While the present invention is amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the presentinvention to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

Certain embodiments of the present invention are directed to apparatus,systems and methods for performing thoracotomy modalities to repairheart valves in either a beating heart or a heart during cardiopulmonaryby-pass; or thoracoscopic repair of heart valves in a beating heart. Adevice that can be used for these purposes is depicted generally withreference numeral 100.

Although the methods and apparatuses of the present invention can beused for any number of treatments requiring the delivery andmanipulation of a suture, the present invention, according to certainembodiments, is generally intended for use in treating a heart conditionknown as mitral valve regurgitation (MR). Mitral valve regurgitation,which is also commonly referred to as mitral insufficiency or mitralincompetence, is a condition characterized by failure of the mitralvalve to close properly. When the mitral valve does not close tightly,blood is allowed to flow backward in relation to its normal flow pathwithin the heart. As many as one in five people over fifty-five years ofage have some degree of mitral valve regurgitation.

As depicted in FIGS. 44-45 , the heart has four chambers. The two upperchambers, called the left and right atria, receive blood. The two lowerchambers, called the left and right ventricles, pump blood. Four valvesaid in directing blood flow through the heart's chambers. These heartvalves open and close, allowing blood to flow in only one direction.

A mitral valve is depicted illustratively in FIGS. 43-45 . Situatedbetween the left atrium and left ventricle, the mitral valve consists oftwo flaps of tissue, or leaflets. The mitral valve annulus forms a ringaround the valve leaflets, thereby connecting the leaflets to the heartmuscle. Papillary muscles are located at the base of the left ventricle.Anchoring the mitral valve leaflets to the papillary muscles aretendon-like cords called chordae tendineae. Normal chordae tendineaeprevent the leaflets from prolapsing, or inverting, into the leftatrium, as depicted in FIG. 45A.

Under normal cardiac conditions, the left atrium contracts and forcesblood through the mitral valve and into the left ventricle. As the leftventricle contracts, hemodynamic pressure forces the mitral valve shutand blood is pumped through the aortic valve into the aorta. For themitral valve to shut properly, the valvular edges of the valve leafletsmust form a non-prolapsing seal that prevents the backflow of bloodduring left ventricular contraction.

A properly functioning mitral valve opens and closes fully. When themitral valve fails to fully close, as depicted in FIG. 45B, blood fromthe left ventricle is able to flow backward into the left atrium insteadof flowing forward into the aorta. This backflow of blood through theheart valve is called regurgitation. The regurgitation of blood throughthe heart due to the failure of the mitral valve to close properly isthe condition known as mitral valve regurgitation. A common symptom ofmitral valve regurgitation is congestion of blood within the lungs.

When blood regurgitates from the left ventricle into the left atrium,such as due to MR, less blood is pumped into the aorta and throughoutthe body. In an attempt to pump adequate blood to meet the blood needsof the body, the left ventricle tends to increase in size over time tocompensate for this reduced blood flow. Ventricular enlargement, inturn, often leads to compromised contractions of the heart, however,thereby exacerbating the congestion of blood within the lungs. If leftuntreated, severe MR can eventually lead to serious cardiac arrhythmiaand/or congestive heart failure (CHF).

Mitral valve regurgitation can be caused by any number of conditions,including mitral valve prolapse (a condition in which the leaflets andchordae tendineae of the mitral valve are weakened resulting in prolapseof the valve leaflets, improper closure of the mitral valve, and thebackflow of blood within the heart with each contraction of the leftventricle), damaged chords (wherein the chordae tendineae becomestretched or ruptured, causing substantial leakage through the mitralvalve), rheumatic fever (the infection can cause the valve leaflets tothicken, limiting the valve's ability to open, or cause scarring of theleaflets, leading to regurgitation), endocarditis (an infection insidethe heart), deterioration of the mitral valve with age, prior heartattack (causing damage to the area of the heart muscle that supports themitral valve), and a variety of congenital heart defects. Normally,mitral valve regurgitation does not pose a serious health threat. As MRbecomes exacerbated over time, however, the condition can become moresevere, resulting in life-threatening complications, including atrialfibrillation (an irregular heart rhythm in which the atria beatchaotically and rapidly, causing blood clots to develop and break looseand potentially result in a stroke), heart arrhythmias, and congestiveheart failure (occurring when the heart becomes unable to pumpsufficient blood to meet the body's needs due to the strain on the rightside of the heart caused by fluid and pressure build-up in the lungs).

According to certain embodiments, the present invention generallyreduces the need to treat mitral valve regurgitation in most individualswith a sternotomy and cardiopulmonary bypass surgery. Specifically, thepresent invention can provide a minimally invasive treatment of MR. Thistreatment significantly decreases trauma to surgical patients byfacilitating transapical access of a beating heart via a lateralthoracotomy, as depicted in FIG. 46 , in a manner that eliminatescertain surgical steps normally required to complete mitral valve repairprocedure by sternotomy.

Transapical access to a heart includes all entry points that are withinapproximately the bottom third of the heart. As used in this patentapplication, transapical access to a heart includes all directions ofentry and points of entry, as well as all angles of entry at each entrypoint.

According to certain embodiments, the present invention is compatiblewith, and directed to percutaneous access to the heart. According toother embodiments, the present invention is compatible with, anddirected to other access points to a heart.

Referring to FIG. 1B, device 100 may include handle assembly 300,capture assembly 302, and needle 138 according to an embodiment of thepresent invention. Handle assembly 300 generally has distal end 304 andproximal end 306. Handle assembly includes shaft 308 and actuator 309.Shaft 308 extends from distal end 304 of handle assembly 300 and isgenerally adapted to be extended into the chest cavity of a patient.Actuator 309 is positioned proximate proximal end 306. Capture assembly302 generally has distal portion 310 and proximal portion 312. Distalportion 310 includes clamping mechanism 314 formed by first clamping jaw316 and second clamping jaw 318. In an embodiment, clamping mechanism314 is adapted to grasp and release a valve leaflet. In a furtherembodiment, first clamping jaw 316 or second clamping jaw 318 isselectively positionable along a longitudinal axis of capture assembly302 in response to actuation of actuator mechanism 314 to create a spacebetween the interior surfaces (not shown) of the first and secondclamping jaws 316, 318.

Referring to FIG. 1A, device 100 can deliver and manipulate a suture ina beating heart and generally includes a handheld suture deploymentdevice 118, and capture confirmation system 101, according to anembodiment of the invention. The handheld suture deployment device 118generally includes a suture cartridge 102, a shaft 104, a handle 106,and a needle assembly 116. Capture confirmation system 101 generallyincludes fiber optic cable assembly 108, and leaflet captureverification (LCV) monitor 110. Although device 100 can be used for anynumber of purposes without departing from the spirit or scope of thepresent invention, the aforementioned platform of components, as isdescribed hereinafter in further detail, enable the extending of a shaftthrough the chest cavity and into a beating heart chamber to capture avalve leaflet of a valve needing repair, and to further provide a needleto operably penetrate the captured valve leaflet and draw a suturetherethrough

Suture cartridge 102 may be pre-loaded suture cartridge 120 or operatingroom-loaded cartridges 122. Referring to FIG. 5 , pre-loaded suturecartridge 120 can include a tapered lower clamp jaw 124, a suture 112, asuture retention system 130, a handle interface 174, a channel 131, anda groove on the clamp surface 162 a. Suture cartridge 120 has proximal198 and distal 196 ends. The lower clamp jaw 124 is located at thedistal end 196 of suture cartridge 120. The handle interface 174 islocated at the proximal end 198 of suture cartridge 120. Channel 131 isprovided with a pair of openings, a first opening which is located onthe top surface, and a second opening which is located on the bottomsurface of suture cartridge 120. Channel 131 runs vertically throughsuture cartridge 120, and is located near the proximal end 198 of suturecartridge 120, such that channel 131 and handle interface 174 arelocated generally adjacent to one another. Intermediate channel 131 andlower clamp jaw 124 is a cartridge shaft 176.

Referring to FIGS. 4A-4E, 4G-4J and FIG. 5 , lower clamp jaw, or distaltip portion, 124 is provided on the distal end of suture cartridge 120according to an embodiment of the invention. For example, lower clampjaw 124 and upper clamp jaw 128 may work cooperatively to form a lowprofile, tapered tip grasping device. Lower clamp jaw 124 generallyincludes a low profile tip 180, a lumen 182, a groove 162, a lower clampsurface 126 and two channels 163. Lumen 182 extends from the distal endto the proximal end of lower clamp jaw 124, parallel to the axis ofcartridge shaft 176. Lumen 182 can be substantially straight, with aninner diameter adapted to receive needle end 146. Groove 162 can beeither groove 162 a or groove 162 b.

According to an embodiment of this invention, groove 162 a is disposedon lower clamp surface 126, and is located laterally along surface 126,as depicted in FIG. 4D. The depth and width of groove 162 a is generallyequal to, or greater than, the diameter of suture 112.

According to an embodiment, groove 162 b is disposed on the uppersurface of lower clamp surface 126, as depicted in FIGS. 4G-4J. Thedepth and width of groove 162 b is generally equal to, or greater than,the diameter of suture 112. For embodiment of this invention wheregroove 162 is groove 162 b, cutout 161 is provided, as depicted in FIGS.4G, 4I, and 4J. Cutout 161 is generally a groove that is parallel with,and has a width that is generally at least equal to the diameter oflumen 182. The distal end of cutout 161 joins with groove 162 b and theproximal end extends to surface 126. The depth of cutout 161 extendsfrom the surface of lower clamp jaw 124 to the centerline of lumen 182.

According to an embodiment, a lower clamp surface 126 is defined by thegenerally planar canted surface of lower clamp jaw 124. Clamping plane129 is the planar distal face of upper clamp jaw 128. Clamp 114 is in aclosed position when lower clamp surface 126 contacts clamping plane129. Lower clamp surface 126 has a surface finish generally suitable forretaining a grasped valve leaflet. Suitable surface finishes include astriated or textured surface finish. As depicted in FIGS. 4D, 41-4J, and5 , a suitable surface finish may include a series of groves and ridges.

According to an embodiment, the proximal opening of lumen 182 is locatedto intersect groove 162 a, as depicted in FIG. 4D and view A of FIG. 5 .According to another embodiment, the proximal opening of lumen 182 islocated to intersect groove 162 b, as depicted in FIGS. 4I and 4J.

According to an embodiment, the low profile tip 180 is generally smoothin shape and surface finish, and is generally free of sharp edges orpoints. The low profile tip 180 is sufficiently large so that whenneedle assembly 116 is in a fully extended position, needle end 146 doesnot protrude from the distal opening of lumen 182.

According to an embodiment, cartridge shaft 176 is provided with across-sectional profile that is compatible to be slidably retainedwithin cartridge channel 172. Cartridge shaft 176 is relatively wide, incomparison to the diameter of shaft 104, as depicted in FIGS. 50-53 . Inan embodiment, the width of cartridge shaft 176 is approximately 65% ofthe diameter of shaft 104. In another embodiment, the width of cartridgeshaft 176 is between approximately 65% and approximately 100% of thediameter of shaft 104. In another embodiment, the width of cartridgeshaft 176 is less than approximately 65% of the diameter of shaft 104. Awide cartridge shaft 176 can prevent body tissue from entering clamp 114from the bottom and presenting a false capture by capture confirmationsystem 101.

According to an embodiment, groove 178 is longitudinally disposed alongthe centerline of the top surface of shaft 176. The depth of groove 178is generally equal to, or greater than, the diameter of suture 112. Thecross-sectional area is generally sufficient to simultaneously encompassthe cross-sectional area of two sutures 112.

According to certain embodiments of this invention, channels 163 areprovided along a portion of the proximal surface of lower clamp jaw 124,as depicted in FIG. 5A. The depth of channels 163 is generally equal to,or greater than, the diameter of suture 112. As depicted in FIG. 5A(view A cartridge in phantom), channels 163 also form a combined cavitythat extends generally from the bottom surface of lower clamp jaw 124 tothe distal top surface of cartridge shaft 176. The proximal ends ofchannels 163 open to groove 178, and the proximal end of groove 178opens to channel 131, thus providing a continuous path for suture 112.

According to an embodiment of this invention, suture 112 is fed throughthe suture cartridge 120, as depicted in FIG. 5 . The length of suture112 is generally divided into two halves, with the mid-point of thesuture length generally located within groove 162 a. Suture 112 runsalong the entire length of groove 162 a and channels 163. Suture 112 isalso located within groove 178 and channel 131. The two free ends ofsuture 112 extend through channel 131.

The suture retention system 130 may generally include a J-shaped flatspring located near the proximal end of suture cartridge 120. Thestraight portion of the “J” is generally parallel with, and locatednear, the top surface of suture cartridge 120. The curved portion of the“J” generally descends into channel 131. The suture retention system 130is positioned such that the curved portion of the “J” forms aninterference fit with the distal wall of channel 131. The sutureretention system 130 acts to retain suture 112 in place within suturecartridge 102 by applying a frictional force on the portion of suture112 that passes through channel 131. The frictional force generally actsto retain suture 112 as fed within suture cartridge 102. Sutureretention system 130 can release suture 112 once needle 138 has beenadvanced to a fully extended position, as depicted in FIG. 8C.

According to an embodiment, handle interface 174 is located on theproximal end 198 of suture cartridge 120. Handle interface 174 isprovided with suitable structure for being releasably retained withinhandle 106. Handle interface 174 may also be provided with suitablestructure for being releasably retained within plunger assembly 152.Suitable structure may include, for example, latches, screws, frictionfit attachments, and the like.

As depicted in FIGS. 5B, 9 and 10 , a cavity located on the lowersurface of handle interface 174 is provided. This cavity mates with acatch mechanism located on the lower surface of suture cartridgeinterface 184. Thus, handle interface 174 is releasably retained tosuture cartridge interface 184, within the housing of handle 106, due tothe catch mechanism mating with the cavity. Retention of handleinterface 174 can be released through operation of release button 160.

According to an embodiment, operating room loaded cartridges 122 aresubstantially similar in form fit and function to pre-loaded suturecartridges 120, except that operating room loaded cartridges 122 are notprovided with a suture 112.

According to certain embodiments of the invention, shaft 104 has adistal end and a proximal end, as depicted in FIG. 1A. Shaft 104generally includes lumen 134, upper clamp jaw 128, cartridge channel172, and at least one fiber optic bundle 136. In one embodiment, shaft104 includes two or more fiber optic bundles 136. In an embodiment,shaft 104 includes four fiber optic bundles 136.

Shaft 104 generally has a diameter that is approximately 6.5millimeters. The diameter can be greater or less than approximately 6.5millimeters, however, without departing from the spirit or scope of thepresent invention. Upper clamp jaw, or proximal tip portion, 128 islocated at the distal end of shaft 104, and handle 106 is located at theproximal end. Referring to FIG. 4F, cartridge channel 172 defines anopening at the distal end of shaft 104. Cartridge channel 172 may be akeyed channel that runs for substantially the full length of shaft 104,and is substantially axially parallel to shaft 104. As a result of itsprofile, which generally includes two shoulders, cartridge channel 172acts to retain suture cartridge 102.

In one embodiment, shaft 104 generally has a diameter that is less than12 millimeters. In another embodiment, shaft 104 generally has adiameter that is less than 9 millimeters.

In one embodiment, shaft 104 generally has a tapered region 200 at thedistal end of shaft 104 and a substantially uniform region extendingproximally from the tapered region, as depicted in FIG. 1A. The uniformregion being substantially uniformly cylindrical and the tapered regiontransitioning from a substantially circular end to a substantiallyoblong end. In one embodiment, tapered region 200 is betweenapproximately one centimeter and ten centimeters in length. In anotherembodiment, tapered region 200 is between approximately two centimetersand five centimeters in length. In another embodiment, tapered region200 is between approximately four centimeters and five centimeters inlength.

In one embodiment, tapered region 200 has a substantially uniformtop-to-bottom height that is between approximately one quarter of onecentimeter and two centimeters. In another embodiment, tapered region200 has a substantially uniform top-to-bottom height that is betweenapproximately one-half-of-one centimeter and one and one-quarter-of-onecentimeters. In another embodiment, tapered region 200 has asubstantially uniform top-to-bottom height that is approximately 0.81centimeters.

In one embodiment, the uniform region of shaft 104 has a substantiallycircular cross-section, and the substantially oblong end of taperedregion 200 has a side-to-side width that is less than the diameter ofthe uniform region. In another embodiment, the side-to-side width of theoblong end of tapered region 200 is approximately between approximatelytwenty-five millimeters and two and one-half millimeters less than thediameter of the uniform region.

Lumen 134 is substantially axially parallel with both shaft 104 andcartridge channel 172, according to certain embodiments of theinvention. Lumen 134 defines an opening 135 on the planar distal surfaceof upper clamp jaw 128 and a proximal opening in handle 106. Lumen 134is generally substantially straight. The inner diameter of lumen 134 isgenerally appropriately sized to accommodate needle assembly 116 wheninserted alone, and needle assembly 116 when extracted with a capturedsuture 112. Lumen 134 is substantially co-axial with lumen 182

According to certain embodiments of the invention, fiber optic bundles136 are positioned within shaft 104. Each fiber optic bundle 136generally includes two fiber optic strands. Each fiber optic bundle 136functionally terminated at clamping plane 129, such that a light inputto one of the fiber optic strands results in a reflected, or refractedoptical signal that is detectable by the other fiber optic strand withina fiber optic bundle 136. Such a reflected or refracted optical signalmay correspond to the nature and color of any material that is presentat, or in proximity to, clamping plane 129. Fiber optic bundles 136 areoperably connected through fiber optic cable assembly 108 to the leafletcapture verification (LCV) monitor 110.

As depicted in FIGS. 4A-4E and 4G-4J, lower clamp jaw 124 and upperclamp jaw 128 work cooperatively to form clamp, or bifurcated tip, 114.According to certain embodiments of the invention, clamp 114 which isgenerally bifurcated, low-profile, and tapered so as to perform anynumber of grasping functions.

Through the actuation of plunger assembly 152, lower clamp jaw 124 canbe extended distally from upper clamp jaw 128, and can be retracted.When lower clamp jaw 124 is fully retracted, clamp 114 is in a closedposition. In the closed position, lower clamp surface 126 contactsclamping plane 129. In the closed position, the outer surfaces of upperclamp jaw 128 and the outer surfaces of lower clamp jaw 124 aresubstantially coextensive. In a closed position, the outside surfaces oflower clamp jaw 124 and upper clamp jaw 128 form a substantially smoothsurface such that no snagging, rough, or sharp edges or overlaps areformed. When lower clamp jaw 124 is extended, clamp 114 is in an openposition. In an open position, lower clamp jaw 124, and upper clamp jaw128 can be positioned around a piece of tissue, such as a mitral valveleaflet. Through the relative movement of lower clamp jaw 124, clamp 114is operable to capture a valve leaflet, and needle 138 can penetrate thecaptured valve leaflet via lumens 134, 182.

According to certain embodiments of the invention, clamp 114 presents anoversized leaflet capture area compared to the cross-sectional area ofshaft 104.

In a closed position, the outside surfaces of lower clamp jaw 124 andupper clamp jaw 128 form a substantially smooth surface, according tocertain embodiments of the invention. This smooth surface can facilitatethe insertion of clamp 114 into a tissue opening that is smaller thanthe clamp's cross-sectional area due to the elasticity of tissue overshort periods of time. For the embodiments of the invention depicted inFIGS. 4A-4E and 8 , the shaft diameter is approximately 85% of themaximum diameter of clamp 114. By employing this ratio of clamp-to-shaftdiameters, body tissues can be stretched within their elastic limits,which permits an oversized leaflet capture area within clamp 114 ascompared to the cross-sectional area of shaft 104.

An oversized leaflet capture area, as compared to the shaft's 104cross-sectional area, is presented due to the clamping angle θ,according to certain embodiments of the invention. Clamping angle θ isthe angle that clamping plane 129 makes with a horizontal plane throughthe centerline of shaft 104 as indicated by θ on FIG. 4C. For theembodiments of the invention depicted in FIG. 4C, clamping angle θ isapproximately 120 degrees. In other embodiments of the invention,clamping angle θ is approximately between 115 degrees and 125 degrees.In other embodiments of the invention, clamping angle θ is approximatelybetween 90 degrees and 135 degrees. In still other embodiments of theinvention, clamping angle θ is approximately between 135 degrees and 155degrees. A clamping angle that is greater than 90 degrees may result ina leaflet capture area of clamp 114 that is larger, relative to shaft's104 cross-sectional area, than would be possible were the clamping angle90 degrees. For a clamping angle that is approximately 120 degrees, theleaflet capture area of clamp 114 will be approximately 30% to 40%larger than if the clamping angle were 90 degrees.

In an embodiment of the present invention, a canted tip with increasedclamp travel improves leaflet capture. In another embodiment of thepresent invention, an exchangeable cartridge improves the simplicity andreliability of suture deployment. In another embodiment of the presentinvention, a suture deployment and manipulator mechanism is integratedwith a visualization and verification system to deploy sutures within asuture zone of a valve leaflet.

According to certain embodiments of the invention, clamp 114 is a lowprofile tapered tip grasping device. The shape of the tapered tipfacilitates leaflet capture by providing a large surface area forleaflet capture, relative to the diameter of the shaft. In oneembodiment, the surface area for leaflet capture is between 30% and 50%greater than the cross-sectional area of the shaft 104. In anotherembodiment, the surface area for leaflet capture is between 20% and 100%greater than the cross-sectional area of the shaft 104.

According to certain embodiments of the invention, clamp 114 is a lowprofile canted tip grasping device. Clamp 114 can be canted in anynumber of directions. Generally, however, the canted tip is canted up,as depicted in FIGS. 54-55 . A large surface area of the canted tip,relative to the diameter of the shaft, facilitates leaflet capture.

A large leaflet capture area can provide a surgeon with certainadvantages as compared to a smaller leaflet capture area. Theseadvantages include improved ability to capture a leaflet that may bedamaged or enlarged and a leaflet capture that is more stable. Greaterstability in turn can provide a surgeon enhanced control of a capturedleaflet.

According to an embodiment of the invention, the maximum linear travelof lower clamp jaw 124 in relation to upper clamp jaw 128 is betweenapproximately one and five centimeters. According to another embodimentof the invention, the maximum linear travel of lower clamp jaw 124 inrelation to upper clamp jaw 128 is between approximately two and threecentimeters. According to certain embodiments of the invention, handle106 is formed to be manipulated by an operator. Operator may be, forexample, a surgeon, or the controllable device-interfacing end of arobotic system. In one embodiment, handle 106 is adapted to be graspedby the index and middle finger of a surgeon. Shaft 104 extends from thedistal end of handle 106, and plunger assembly 152 is retained in theproximal end. As depicted in FIG. 9 , structure is provided withinhandle 106 to retain plunger assembly 152 such that plunger assembly 152is permitted to engage with suture cartridge 102, and to translate inboth the distal and proximal directions. Suitable structure forretaining plunger assembly 152 within handle 106 include, for example, apin and shackle arrangement, a retaining collar, a boss within a groove,and the like. As depicted in FIGS. 9 and 11 , a pin and retainingshackle arrangement is employed, with the pin biased against spring 158within slot 132 of plunger shaft 156, in order to permit translationalmovement of plunger assembly 152. Release button 160 is located on thebottom surface of handle 106, as depicted in FIG. 10 . Release button160 transfers an operator's input to the retaining structure of handleinterface 174 in order to uncouple suture cartridge 102 from plungerassembly 152. A track may also be provided on the top surface of handle106 that accepts needle carriage 144. Markings are provided on the topsurface of the handle, adjacent to the track, to aid an operator inpositioning needle carriage 144.

As depicted in FIGS. 9 and 11 , plunger assembly 152 generally includesplunger thumb handle 154, plunger shaft 156, suture cartridge interface184 and spring 158, according to certain embodiments of the invention.Plunger thumb handle 154 is formed to be grasped by the thumb of anoperator and is provided on the proximal end of plunger assembly 152.Suture cartridge interface 184 is provided on the distal end of plungerassembly 152 and is formed to engage and releasably retain suturecartridges 102. Intermediate suture cartridge interface 184 and plungerthumb handle 154 is plunger shaft 156. Slot 132 is located along aportion of the length of plunger shaft 156. Spring 158 is located withinslot 132 of plunger shaft 156, and in cooperation with a pin andretaining structure within handle 106, serves to bias plunger assembly152 to a proximal position relative to handle 106. As a result of thereleasable retention between suture cartridge interface 184 and suturecartridges 102, the biasing action of spring 158 is translated to suturecartridge 102. This biasing action favors retention of clamp 114 in aclosed or grasping position. Biasing of plunger 152 in this mannerfacilitates slow and incremental clamp extension and contraction.

In one embodiment, spring 158 favors retention of clamp 114 in a closedor grasping position with a force in the range of approximately zeropounds per inch of travel to twenty pounds per inch of travel. In oneembodiment, spring 158 favors retention of clamp 114 in a closed orgrasping position with a force of approximately five pounds per inch oftravel.

As illustrated in FIG. 7 , certain embodiments of needle assembly 116generally include needle 138, needle handle 140, and needle head, orneedle end, 146. Needle 138 is formed from 304 stainless steel wire orother suitable material, is generally circular in shape, and has adistal end and a proximal end. Needle end 146 is provided on the distalend of needle 138 and needle handle 140 is provided on the proximal endof needle 138. Needle end 146 is flattened and a notch 148 is providedto create hook 150. Notch 148 is equal to, or greater than, the diameterof suture 112. Needle handle 140 generally includes finger tabs 142, andneedle carriage 144. Needle carriage 144 is permitted to travel along atrack that is provided within the top housing of handle 106. Such travelpermits needle 138 from moving from a starting position (needle end 146is within upper clamp jaw 128, as depicted in FIG. 51 ) to a fullyextended position (needle hook 150 within lumen 182). Needle carriage144 is also permitted to travel in a proximal direction along the track,such proximal travel extending to a position where needle carriage 144disengages from the track, and needle assembly 116 is removed from thehandheld device 118. Markings provided adjacent to the track aid anoperator in selecting the correct position of the needle carriage 144 inorder to achieve a desired position of needle 138. A detent is alsoprovided to aid in locating the starting position of needle assembly138. Finger tabs 142 fan out from the centerline of needle assembly 116and in so doing, act to prevent needle carriage 144 from beinginadvertently displaced. In order for an operator to displace needlecarriage 144, an operator must first grasp and press finger tabs 142together, and then needle carriage 144 can be displaced along the track.In one embodiment, a biasing member opposes the movement of needlecarriage 144 to a distal position.

According to certain embodiments of the invention, fiber optic cableassembly 108 generally includes fiber optic cable 166 and strain relief164. Fiber optic cable 166 generally includes four (4) fiber opticbundles 136 that run from the distal surface of upper clamp jaw 128 tothe leaflet capture verification (LCV) monitor 110. The four (4) fiberoptic bundles 136 are bundled together within fiber optic cable 166 andare jacketed with a medical grade PVC cover, or other suitable coveringmaterial. Strain relief 164 is provided at the interface between fiberoptic cable 166 and leaflet capture verification (LCV) monitor 110 asdepicted in FIG. 12 .

According to certain embodiments of the invention, fiber optic cableassembly 108 is at least two-hundred-and-twenty centimeters long. Forthese embodiments, in an operating room setting, LCV monitor 110 can beplaced outside of the sterile field, which results in the option topackage device 100 in such a manner that LCV monitor 110 need not besterilized.

According to another embodiment, a fiber optic connector (not depicted)can be used to operably connect fiber optic cable assembly 108 to LCVmonitor 110. The use of such a connector permits the sterilization andsterile packaging of the handheld device 118 and fiber optic cableassembly 108, while the LCV monitor 110 can be separately packaged in anunsterilized condition. In an operating room setting, handheld device118 and fiber optic cable assembly 108 can be introduced into thesterile field, while LCV monitor 110 can be placed outside of thesterile field, within surgical line-of-sight of a TEE monitor, and thefiber optic connector used to operably connect LCV monitor 110 and fiberoptic cable assembly 108.

As depicted in FIGS. 12 and 13 , leaflet capture verification (LCV)monitor 110 generally includes power button 168, four (4) LED displays170, housing 186, circuit board 188, and an internal power supply 190,according to certain embodiments of the invention. Housing 186 includesan integrated loop which is adapted to be securely clipped or hung suchthat the LED displays 170 of LCV monitor 110 can be placed withinsurgical line-of-sight of a TEE monitor. Disposed on circuit board 188is internal power supply 190, power button 168 and a light source, suchas an LED. For other embodiments, more than one light source can beused. Circuit board 188, internal power supply 190, power button 168,and the light source are all operably connected in a manner familiar tothose who are skilled in the art. Activation of power button 168 resultsin the light source being turned on/off. Four sets of fiber opticbundles 136 enter housing 186 via fiber optic cable 166 and strainrelief 164. Each fiber optic bundle 136 generally includes two fiberoptic strands. For each fiber optic bundle 136, one of the fiber opticstrands is operably connected to the light source, while the other fiberoptic strand is operably connected to one of the four (4) LED displays170. Power button 168, the four (4) LED displays 170, circuit board 188,the an internal power supply 190, and the light source(s) are allcontained within housing 186. The four (4) LED displays 170 are visibleto an operator from outside of housing 186, and power button 168 isoperable from outside of housing 186.

In operation, device 100 can be used to attach a suture within thesuture target zone 194 of a valve leaflet, as depicted in FIG. 43 . Toaccomplish this, the device 100 may employ a visualization andverification system. The visualization and verification systemintegrates external transesophageal echocardiography (TEE) to visualizea valve leaflet in multiple axes and fiber optics to verify leafletcapture. In an embodiment, suture target zone 194 is generally twomillimeters from the leading (prolapsing) edge of the leaflet. Inanother embodiment, suture target zone 194 is one millimeter wide andhas a centerline that is located two millimeters from the leading(prolapsing) edge of the leaflet. In another embodiment, suture targetzone 194 is one millimeter wide and has a centerline that is locatedthree millimeters from the leading (prolapsing) edge of the leaflet. Inanother embodiment, suture target zone 194 is one millimeter wide andhas a centerline that is located four millimeters from the leading(prolapsing) edge of the leaflet. In another embodiment, suture targetzone 194 is greater than one millimeter wide and has a centerline thatis located between two millimeters and five millimeters from the leading(prolapsing) edge of the leaflet. In another embodiment, suture targetzone 194 is less than one millimeter wide and has a centerline that islocated between two millimeters and five millimeters from the leading(prolapsing) edge of the leaflet. In one embodiment, the fiber opticsinclude a leaflet capture verification (LCV) monitor 110 and a fiberoptic cable assembly 108, as depicted in FIGS. 1A and 12 .

Referring to FIGS. 4E and 4F, in an embodiment, fiber optic bundles 136terminate at upper clamp jaw 128 in a configuration that surrounds lumenopening 135. In another embodiment, fiber optic bundles 136 terminate atupper clamp jaw 128 in a configuration that is near lumen opening 135.Those skilled in the art will realize that many variations in theconfiguration of the placement of the terminations of fiber opticbundles 136 at clamping plane 129 are possible in order to meet thespirit and scope of the present invention. The identification of certainconfigurations is not intended to exclude others which are notidentified, but are provided as examples of possible configurations.

Fiber optic bundles 136 are operably connected through fiber optic cableassembly 108 to the leaflet capture verification (LCV) monitor 110,according to certain embodiments of the invention. When a valve leaflethas been grasped in clamp 114, the LCV monitor 110 displays a lighttransmission that corresponds to the configuration of fiber opticbundles 136 at clamping plane 129, and which identifies whether thevalve leaflet is properly captured in clamp 114.

According to certain embodiments, the present invention can be used withrobotic multi-axis control and manipulation of the device. Proximalcontrol of the instrument can be achieved with a system interfacecomprised of the necessary electrical and electro-mechanicalinterconnects to actuate the mechanical operations of the instrument.According to an embodiment, the distal tip of the device can have arigid shaft. According to another embodiment, the distal end of thedevice can have an articulating, multiple axis tip for orientation ofthe clamp and suture delivery.

According to certain embodiments of the invention, the movable tiptypically remains in the closed position during thoracoscopic insertionand manipulation of the handheld device 118. As desired by an operator,plunger 152 can be manipulated to separate the two portions of themoveable tip, as depicted in, for example, FIGS. 4D-4E, 4G-4J and 49 .

According to certain embodiments of the invention, clamp 114 is biasedto a closed position through the use of spring 158, or other biasingmember. A clamp that is biased closed aids in leaflet captureverification as it can provide a surgeon with a distinctive tactilefeedback when a leaflet has been captured, as compared to when theresult is a failed or partial leaflet capture.

In practice, certain embodiments of the present invention can be used toattach a suture to the suture zone of a valve leaflet in a beatingheart, as depicted in FIGS. 14-42 and 46-48 . In one embodiment, theapex of the left ventricle is accessed. Such access can be obtained bythoracotomy or other suitable surgical technique. Shaft 104 of thehandheld suture deployment device 118 is then inserted through the apexof the heart into the left ventricle using transesophagealechocardiography (TEE) to guide the surgeon. A purse string suture atthe site of left ventricular apical access can be used to control bloodloss.

As depicted in FIGS. 14-16 , while the heart is beating, the movable tipof the platform is used to guide the capture of a flailing leaflet asclamp 114 is closed. A surgeon can use external transesophagealechocardiography to guide the placement of the movable tip relative to atarget leaflet. Through further use of transesophageal echocardiography,as well as the tactile feel of plunger 152, and LCV monitor 110, asurgeon can verify leaflet capture.

Once the leaflet is captured, a surgeon can verify capture by examiningthe leaflet capture verification (LCV) monitor 110 to assure leaflettissue is present. In an embodiment, the four LED displays 170 of theLCV monitor 110 present red when blood is present at clamping plane 129,as depicted in FIG. 17 , while a display of four white lights indicatesthat the tissue has been fully captured by the movable tip, as depictedin FIG. 18 .

In one embodiment, an operator can penetrate the leaflet with needle 138and retrieve secured suture 112 from the lower clamp jaw 124 by engagingneedle assembly 116. First, needle 138 is advanced by guiding the needleassembly carriage 144 forward, or toward the distal end of the platformas depicted in FIGS. 19-24 (the movable tip is illustrated in phantom inFIGS. 21-24 so that the advancement of needle 138 can be visiblydepicted). Once needle 116 is fully advanced, the needle assembly isrotated to engage suture 112 as depicted in FIGS. 25-27 (the movable tipis illustrated in phantom in FIGS. 25-27 so that the rotation of needle138 can be visibly depicted). The suture loop is retrieved by retracting(movement is in the proximal direction) the needle assembly entirelyfrom handheld device 118 as depicted in FIGS. 28-32 . The handhelddevice 118 can then be extracted from the ventricle while maintainingcontrol of both ends of the suture as depicted in FIGS. 33-35 .

In another embodiment, no rotation of needle 138 is necessary. A surgeonadvances needle 138 by guiding the needle assembly carriage 144 forward,or toward the distal end of the platform as depicted in FIG. 8C. Onceneedle 116 is fully advanced, needle hook 150 engages with suture 112,as depicted in FIG. 8 , when needle assembly carriage 144 is retractedas depicted in FIG. 8D. Needle hook 150 can advance past suture 112without dislodging suture 112 from groove 162 because suture retentionsystem 130 acts to retain suture 112 as threaded on and within suturecartridge 102. Suture retention system 130 releases suture 112 onceneedle 138 has been is fully advanced.

In embodiments of the invention that have cutout 161, handheld device118 can be extracted with clamp 114 in a closed position. This isbecause cutout 161 permits suture 112 to be clear of clamp 144 after thesuture loop is retrieved from handheld device 118. Extracting handhelddevice 118 with clamp 114 in a closed position facilitates theextraction. In one embodiment, the non-loop end of the suture 112 ispassed through the loop to create a girth hitch on the leaflet asdepicted in FIGS. 36-41 and 47-48 . The girth hitch provides fordistributed stress on the leaflet with two suture legs and avoids theneed for a knot at the site of leaflet capture.

In one embodiment, a surgeon can thread one of the free ends of thesuture 112 into an operating-room loaded cartridge 122 and repeat thecapture process on an adjacent (non-flailing) leaflet to create leafletplication or what is commonly known as the Alfieri stitch. In otherembodiments, the handheld device 118 can be adapted to form differenttypes of knots or stitches that can be used for mitral valve repair.This can be accomplished through changes to one or more of: the relativelocation of the needle within the shaft; the relative orientation of thesuture within the distal tip; the configuration of the suture within thedistal tip; the relative orientation of the needle hook; the addition ofone or more needle ends to the needle assembly; and the relativelocations of multiple needle ends within the shaft.

At this stage, the surgeon can visualize the function of the mitralvalve leaflet using TEE as depicted in FIG. 42 . An operator can thenincrementally adjust the tension on the suture, while monitoring thecorresponding mitral valve regurgitation through the use of TEE, toallow for ideal coaptation of the mitral valve leaflets and consequentlya reduction or elimination of MR. If the competency of the mitral valveis satisfactory, the suture can be secured to a suitable location.Suitable locations for this purpose can include the epicardium, apapillary muscle and other like locations. Securing the suture can beaccomplished using a standard surgical knot and pledget.

In one embodiment of the present invention, the process can be repeatedby removing exchangeable cartridge 102 from the handheld device 118 andreplacing it with a pre-loaded suture cartridge 120. In anotherembodiment, the process can be repeated by removing exchangeablecartridge 102 from the handheld device 118 and threading a suture 112into operating room loaded cartridge 122 which can then be installedinto handheld device 118.

1. A device for repairing a valve leaflet in a beating heart of a patient, comprising: a handle assembly including a shaft extending from a distal end of the handle adapted to be extended into a chest cavity of the patient and an actuator mechanism positioned proximate a proximal end of the handle assembly, the shaft having a diameter and a generally circular cross-section along a longitudinal axis at a distal portion of the shaft that is adapted to pass through an incision in the beating heart; a capture assembly extending from the distal portion of the shaft and adapted to be positioned within the beating heart, the capture assembly having a distal portion including a clamping mechanism adapted to grasp and release the valve leaflet and a proximal portion operably connected to the shaft, the distal portion of the capture assembly having a maximum diameter of an asymmetric cross section transverse to the longitudinal axis of the capture assembly that is greater than the diameter of the shaft, wherein one of a first clamping jaw or a second clamping jaw of the clamping mechanism is selectively positionable along a longitudinal axis of the capture assembly in response to actuation of the actuator mechanism to create a space between interior surfaces of the first clamping jaw and the second clamping jaw having an asymmetric perimeter; and a needle head slidably positionable within the capture assembly to engage a suture at least partially carried by the capture assembly in response to selective activation of a needle by the actuator mechanism as the needle penetrates the valve leaflet, such that an area of the interior surfaces is increased relative to an interior surface area of a circular clamping jaw having a diameter equal to the diameter of the shaft and the capture assembly is rotatable within the heart with reduced blood loss relative to blood loss of rotation of the asymmetric perimeter of the first clamping jaw and the second clamping jaw in the incision of the heart.
 2. The device of claim 1, wherein the first clamping jaw and the second clamping jaw are separable along a bifurcation plane, the bifurcation plane forming a bifurcation angle with the longitudinal axis of the capture assembly, the bifurcation angle being between approximately forty-five degrees and ninety degrees.
 3. The device of claim 2, wherein the bifurcation angle is between approximately fifty-five degrees and approximately sixty-five degrees.
 4. The device of claim 1, wherein the area of the interior surfaces is increased relative to the interior surface area of a circular clamping jaw having a diameter equal to the diameter of the shaft by between 20% and 100%.
 5. The device of claim 4, wherein the area of the interior surfaces is increased relative to the interior surface area of a circular clamping jaw having a diameter equal to the diameter of the shaft by between 30% and 50%.
 6. The device of claim 1, wherein the diameter of the shaft is less than 9 mm.
 7. The device of claim 1, wherein the space between interior surfaces of the first clamping jaw and the second clamping jaw of the distal tip portion when positioned in an open position provides a distance along the longitudinal axis of the capture assembly between interior surfaces of the first clamping jaw and the second clamping jaw of between 1 and 5 cm.
 8. The device of claim 7, wherein the distance along the longitudinal axis of the capture assembly between interior surfaces of the first clamping jaw and the second clamping jaw is between 2 and 3 cm.
 9. The device of claim 1, wherein the capture assembly is configured to penetrate the valve leaflet with the needle head from a distance of between approximately one millimeter and four millimeters from a leading edge of the valve leaflet.
 10. The device of claim 1, wherein the distal portion of the shaft is isodiametric and the proximal portion of the capture assembly includes a tapered region having cross sections that transition from a substantially circular cross section of the distal portion of the shaft to the asymmetric perimeter of the first clamping jaw and the second clamping jaw.
 11. The device of claim 2, wherein the distal portion of the capture assembly has a generally oblong asymmetric egg three dimensional shape, with the bifurcation angle approximately 60 degrees and the asymmetric perimeter of the first clamping jaw and the second clamping jaw generally loaf shaped cross section.
 12. A device for repairing a valve leaflet in a beating heart of a patient, comprising: a shaft having a proximal end outside the patient and a distal end adapted for insertion into the beating heart of the patient; a handle with an actuator operably connected to the proximal end of the shaft; a capture assembly adapted to penetrate the beating heart, the capture assembly being operably coupled to the distal end of the shaft and including a bifurcated tip adapted to grasp the valve leaflet in response to selective actuation of the actuator; and a needle slidably positionable within the capture assembly to penetrate the valve leaflet; wherein the shaft is generally isodiametric and the capture assembly has a cross sectional perimeter that is asymmetric at the bifurcated tip and a maximum diameter of the cross sectional perimeter at the bifurcated tip that is greater than a diameter of a portion of the shaft adapted to be positioned proximate a wall of the beating heart.
 13. The device of claim 12, wherein the handle includes a first actuator extending generally outwardly the handle for lateral operation and a second actuator generally axially along the handle for inline operation.
 14. The device of claim 13, wherein the first actuator extending is operably connected to the needle assembly and the second actuator is operably connected to the capture assembly.
 15. The device of claim 12, wherein the handle defines a first and second spaced-apart aperture and the actuator defines a third aperture, the first, second, and third apertures being adapted to receive fingers of an operator.
 16. The device of claim 12, wherein the handle and the actuator are adapted for robotic control.
 17. The device of claim 16, wherein the robotic control is performed by a multi-axis control system.
 18. The device of claim 17, wherein the capture assembly includes a pivot joint, the pivot joint being operably controllable by the multi-axis control system.
 19. The device of claim 18, wherein the capture assembly is pivotable about at least two axes of rotation. 20-39. (canceled) 